FDA Reports Calcitonin, a Hormone Found in Salmon, Poses Cancer Risk in Drug Treatments

Recent reports from the U.S. Food and Drug Administration state that there could be an increased risk of cancer with drugs containing calcitonin salmon, a man-made version of the hormone that is found in salmon.

Reuters states that in briefing documents released on Friday, reviewers said the risk raises concerns about the overall benefit of the product to treat osteoporosis in postmenopausal women.

These products include Novartis AG's Miacalcin injection and nasal spray and Unigene Laboratories Inc's nasal spray. Privately held Upsher Smith Laboratories Inc distributes Unigene's product in the United states, where generic versions of the drug are also available.

The FDA is scheduled to discuss the risks and benefits of the products on March 9, and will make recommendations to the agency based on the outcome of the meeting to allow the cancellation or continuation of the product.

Last July European regulators recommended that long-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs to just short-term use in Paget's disease, a bone disorder; for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer. Thus, they determined that the benefits did not outweigh the risks.

Novartis said in a statement that it "places the highest priority on patient safety and the appropriate use of its medicines and is looking forward to the opportunity to engage in the discussion at the upcoming meeting."